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CDC Telebriefing Transcript

MMWR Updated Smallpox Response Plan and Guidelines

September 23, 2002

CDC MODERATOR: Thank you very much for joining us. This is Lisa Swenarski, Director of Media Relations at the CDC. Today, we're holding a telebriefing on the Updated Smallpox Response Plan and Guidelines, and we have six people available to answer your questions today.

First, we'll have an opening statement from Joseph Henderson, CDC Associate Director for Terrorism Preparedness and Response, and then also available for questions are Dr. David Fleming, Deputy Director for Science and Public Health at CDC; Dr. Walter Orenstein, Director of CDC's National Immunization Program; Dr. James Hughes, Director of the National Center for Infectious diseases at CDC; and also Dr. Joanne Kono [ph] and Dr. Lisa Rotz, medical epidemiologists.

Now for our opening statement from Joseph Henderson.

MR. HENDERSON: Good afternoon.

The Department of Health and Human Services, Centers for Disease Control and Prevention, today released to state and local public health bioterrorism response planners, state health officials and others an updated version of the Post-Event Smallpox Response Plan and Guidelines.

This plan was originally released on November 21st, 2001, and was previously updated on January 23rd, 2002. This is the third revision to these guidelines since they were released in November, and as you know, we have been working with states for some time to strengthen their ability to respond in the event of a bioterrorism event involving smallpox. This document does not represent the Smallpox Pre-event Plan and Guidelines that will identify which designated groups in the states will be receiving smallpox vaccine prior to such an event.

The purpose of these guidelines is to provide states with important information they can use to effectively and rapidly respond to a smallpox outbreak. The document incorporates many of the comments and suggestions CDC received from state epidemiologists, bioterrorism coordinators, immunization programs, other health care officials and our professional organizations.

The Smallpox Response Plan and Guidelines is a working document that will continue to be updated. Future updates will include infection control, isolation recommendations, outbreak response initiatives, and other related strategies. I should mention that the changes to these Post-Event Smallpox Guidelines, in addition to covering mass vaccination clinic guidelines, there's also new information pertaining to surveillance, and disease investigations forums, and communication strategies.

MR. HENDERSON: Thank you.

We're ready for our first question.

AT&T OPERATOR: Ladies and gentlemen, just a quick reminder, if you do have a question, please press the one at this time.

Our first question is from the line of Marianne Falco with CNN. Please go ahead.

QUESTION: Hi. Thanks for taking our calls.

At what point are you--it seems from what we're reading, it's still voluntary that folks would show up for vaccinations, and the difference being large-scale instead of the ring vaccinations--at what point would you make it mandatory and, as a follow-up, what's the benefits of making this voluntary? Does that put the onus on the person? Does it give the person the right to weigh the pros and cons that are associated with the vaccination? If you can elaborate on that, I'd appreciate that.

DR. ORENSTEIN: The purpose of this plan is to take the next step in getting states ready in the event of an attack, and so the goal and the changes we've made deal with making smallpox available to the total population as rapidly as possible if that is necessary. It doesn't deal with the issue of whether it was voluntary or mandatory, but the goal here is to help states and localities develop the capacity to provide vaccine to very large numbers of people as rapidly as possible.

CDC MODERATOR: That was Dr. Walter Orenstein.

QUESTION: But I'm reading from the first page of the kit you sent out, which says rapid voluntary vaccinations.

DR. ORENSTEIN: Right. This was actually not to address a mandatory thing. The key in smallpox control is two processes: one is placing of contacts and vaccinating those contacts of cases, and the second is this mass-vaccination approach. At least at this point, we are thinking about this in a massive way as a voluntary kind of program.

CDC MODERATOR: Next question, please.

AT&T OPERATOR: That is from the line of Anita Manning with USA Today. Please go ahead.

QUESTION: Thank you, Dr. Orenstein, but I don't think that we quite got an answer to that other question about what is the benefit of making it voluntary, and does this mean that the ring vaccination program is being supplanted by this new one, and why would that have happened?

DR. ORENSTEIN: First of all, this would be complementary to ring vaccination. If there were a case of smallpox anywhere in the country, one would need to do both the ring vaccination techniques, which focuses on vaccinating those most in need and those who are most likely to come down with disease, as well as at the same time be prepared to develop mass vaccination of large populations if that was felt to be necessary.

The issue of mass vaccination would clearly be a more voluntary kind of procedure because it's ring vaccination that is most helpful for actually cutting out transmission of the virus. But by doing a mass vaccination, we give ourselves a greater security, particularly if there's unknown exposures, of limiting spread, as well as allowing the members of the public who want to protect themselves to get themselves protected quickly.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: Larry Altman with the New York Times. Please go ahead.

QUESTION: Yes, can you just outline in just a dingbat or key points how this third revision differs from the first revision. Can you outline the key differences in the steps.

MR. HENDERSON: Yes. This is Joe Henderson. Some of these I had mentioned in my opening statement. I think the critical change is the specificity of the guidelines we're providing around mass vaccination, mass vaccination clinics and the logistics associated with that.

Some of the other changes I had mentioned were new forms for disease surveillance and new forms that could be used to enhance disease investigation and some new information around communication planning.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: And that is from Maggie Fox, Reuters. Please go ahead.

QUESTION: Good morning. Thanks very much for this.

Can I just preface this by saying you have to be kind of on the inside team here to know about this telebriefing. It would be very helpful if perhaps an e-mail went out to people on the CDC or HHS press list informing them about these telebriefings because you guys are going to get deluged with phone calls later.

My question is could you give details about the updates to communications; who communicating with who? Is this HHS down to the clinics or is this communicating to the public and what do they provide for?

DR. ROTZ: I believe the updates to the communications piece are basically helping states formulate their communications plans and telling them about things that they need to put into place for communications in a post-event setting, and it gives more guidance to states and local public health officials on how to do that.

CDC MODERATOR: That was Dr. Lisa Rotz, R-o-t-z.

Just to your first comment, we did send it out on our list serve this morning, the Media Advisory. I'm sorry if you didn't get it.

QUESTION: Oh, okay. Then I apologize for that comment.

Can I follow up on Dr. Rotz's reply? That's not very clear. I'd like to write for a general audience. It helps states formulate communications with whom?

DR. ROTZ: Well, it would be communications for state-level public health authorities for how they would communicate with the public in a post-event setting, as well as how they would communicate with the medical communities and each other. It's multiple communication strategies.

QUESTION: Can you give us some "for instances," what it does?

MR. HENDERSON: This is Joe Henderson. Just let me follow up because I think we can probably apply some of the broad-base communications guidelines that we've issued in support of the state and local cooperative agreement around communications strategies.

Our focus is always communicating with a variety of individuals, the individuals being the health care providers on the front line that would be seeing these patients and who would have to be, obviously, critical to the response.

Communications would be to the general public, through the media, and giving people information that they need so that they understand their potential role if we're in a smallpox outbreak. Even if they're not exposed, there's certain things they can do obviously to protect themselves and their families.

So, generally, the communication guidelines are always geared towards communicating with the whole airwave individuals that need to have this information so that they know how best to enhance response capacities.

Does that help?

QUESTION: Not really. It's still kind of broad, "jargony" language. For instance, does it specify exactly what words you use? Does it give examples of flyers that should go out? Does it give scripts for people to read if they're called on the phone? What exactly does it do?

MR. HENDERSON: I think it's fair to say that the guidelines that we issue are really contingent upon the state and local health agencies taking those guidelines, and then they in turn will develop flyers, they in turn will decide for their particular communities if they need to do something through the TV media or getting things into newspapers.

We provide basic guidance that help them understand how best to communicate with certain audiences, but it's up to them to customize that for their jurisdictions.

CDC MODERATOR: Thank you very much.

Next question, please.

AT&T OPERATOR: It's from Laura Mechler of the Associated Press. Please go ahead.

QUESTION: Hi. Thank you.

My question is, first of all, do you have a target time for which states would have to put this mass vaccination plan into place. The Washington Post story today suggested it was five days. I've read the plan, and I see a reference to ten days. I'm wondering what your thinking is on how long they should, communities should be prepared to--what the time frame they should be prepared to work in and complete their work on vaccinations.

DR. FLEMING: Laura, this is Dave Fleming.

The plan that was sent out was a plan that, from an arbitrary standpoint, we selected one million people and ten days because we wanted to provide states and localities with specificity around logistics--how many people would you need, how many vaccination clinics, et cetera.

The actual time to implement this would be dependent on the circumstance. Our goal would be to protect as many people as possible, with the first part of the vaccination campaign being directed specifically at those who were at highest risk, with subsequent portions being dedicated to those at lower risk. The exact time frame would, therefore, depend on the nature of the circumstance and the part of the country in which it was being performed.

States will be using this information to develop plans that will enable them to deliver these services as absolutely quickly as they possibly can.

QUESTION: All thinking that states need to be prepared to do this within five days; is that time frame significant?

DR. FLEMING: The time frame that we've given in the guidelines is ten days. That can be scaled up or down, depending on the specifics of the circumstances that an individual state is presented with, and so the exact time is not going to be predictable in advance, but it's going to be dependent, again, on what the circumstances are.

QUESTION: Has a decision been made yet as to whether you would, in fact, do a mass vaccination in the event of a smallpox case?

DR. FLEMING: A couple of comments on that.

First, I think it is important to point out that this does not represent any change in policy. Preparing for mass vaccination is something that we all have been talking about for a long time as a complementary strategy to ring vaccination.

QUESTION: So--

CDC MODERATOR: We need to go to the next question.

QUESTION: But there's not been a specific decision made that you would or would not do mass vaccination in any particular instance or has there always been a decision that you would do it?

DR. FLEMING: No, the decision around mass vaccination would be dependent on the particulars of the outbreak that we were facing. In some circumstances, it would be very appropriate to adopt this complementary strategy in addition to ring vaccination; in others, it would not be, but the essentials of preparedness say that we've got to develop the plans right now, so in the eventuality that we're needing to face the circumstance, we would know exactly what to do, and states would be prepared to do it.

CDC MODERATOR: We're ready for the next question, Operator.

AT&T OPERATOR: That's from Tim Reed, London Times. Please go ahead.

QUESTION: Thank you. I was just wondering one question. The types of vaccines that you plan to use, do they reflect a particular strain or strains of smallpox? I've got your document here which says what smallpox is, but are there any particular strains of smallpox that are particularly worrying?

DR. ORENSTEIN: I think the presumption is that the attack would be with variola or variola major, which is the major cause of mortality and overall 30-percent mortality rate.

The vaccines that we would use would be what we had available. At the moment, if we had to do that, we would be using Dryvax as our first choice, which is produced by Wyeth Pharmaceuticals.

As time goes on, there are a number of other vaccines that may become available that we could use in this, but all of them are effective against the form of smallpox we're most concerned about.

My name is Walter Orenstein.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: It's from Cheryl Stahlberg [ph] with the New York Times. Please go ahead.

QUESTION: Hi. I guess I would like to hear more about what scenarios, in your mind, would call this mass vaccination plan into action. So if you could, please, for us, describe a scenario under which this mass vaccination plan would be used and then tell us who will order the mass vaccination plan? Is it up to you folks to initiate it and instruct states to carry it out or can states do it on their own?

Thanks.

DR. ORENSTEIN: I would think this would be in collaboration with the states. The decision to do mass vaccination will be dependent upon an assessment of the magnitude of the attack, the potential duration of the attack, and the mode of the attack and that we would do some form of contact tracing or ring vaccination and vaccination of contacts regardless.

I think the issue of how widespread we would do mass vaccination would be dependent on the assessment of those three factors.

The decisions for mass vaccination would be made in consultation with state and local health officials, as well as Federal health officials.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: And that's with Susan Denser with the NewsHour with Jim Lehrer. Please go ahead.

QUESTION: Thanks. Staying exactly on this theme, is it the understanding that in fact though a decision about mass vaccination would in fact be made at the highest levels? That is to say it would be the Secretary of HHS and/or the White House, just because of the enormous implications of it and the enormous downside risk of vaccinating a lot of people who might have adverse events? What's the--what's the framework under which the decisions are in fact going to be made?

DR. ORENSTEIN: It would be made at that high a level with input from all the other groups that I previously mentioned.

MR. HENDERSON: This is Joe Henderson. Let me just follow up with one additional thing to keep in mind, that if we had a multi-jurisdictional outbreak in the United States and the President was to declare an emergency, of course that would invoke the Federal Response Plan. And, you know, when the Federal Response Plan is invoke, and they tap the component of the Federal Response Plan like health and medical, which would be Emergency Support Function 8, then you'll probably see more decisions coming down from a Federal level to support that Federal Response.

But I think what we're saying for the most part is short of the President declaring an emergency, we would be consulting with our state and local partners to determine the best strategy to control and contain the consequences of the outbreak as it existed at that point.

QUESTION: Just to follow up, if the President declares an emergency, a whole new structure of decision making ensues, a different one. If short of that, essentially it's CDC in conjunction with other state officials, with state officials that drives the process.

MR. HENDERSON: And the Department of Health and Human Services.

QUESTION: And HHS.

MR. HENDERSON: Right.

QUESTION: Okay. Thank you.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: That's from the line of Brian Bechtel with the Infectious Disease News. Please go ahead.

QUESTION: Hi, yes. There seems to be, or there appears to be a change in rhetoric to now allow mass vaccination in certain cases as a complement, and I'm wondering why this change has come about and did the public demand for the vaccine play into this decision?

And I have a quick follow up afterwards.

DR. ORENSTEIN: This is Walt Orenstein. The issue of mass vaccination in a post-attack setting has been one that has been discussed repeatedly, and in fact in June the Advisory Committee on Immunization Practices has as one of its fundamental assumptions the capacity to do mass vaccination of the entire population in a very short period should there be a smallpox attack. So this is just the next natural step, which is to provide a template for states and localities to develop that capacity, but it's continuing to fulfill those recommendations that had been there for some time.

With the increasing availability of vaccine we now have a luxury to do more strategy than we've had when vaccine was completely limited, and so as more and more vaccine comes aboard, the ability to do mass vaccination in the post-attack setting is there.

QUESTION: And as a quick follow up, along the lines of voluntary and compulsory vaccination, would ring vaccination be compulsory, and then mass vaccination be voluntary, or is there some way to decide that?

DR. ORENSTEIN: I think that at the moment those decisions would be made at the local level, that in essence ring vaccination can work quite well with probably a voluntary kind of vaccination, and that we would have to work with people who refused vaccination who were close contacts to assure should they become ill that they do not come in contact with others.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: And that's Sarah Luck with the Wall Street Journal. Please go ahead.

QUESTION: I needed some clarification. If there were a smallpox case or outbreak of some type discovered tomorrow say, is this--how quickly could this plan be brought online? And also it seems to depend on hospitals or clinics being designated smallpox facilities, and I know there's been some trouble doing that. I just wondered if there had been any change in the last couple months, if communities are identifying places where patients would go.

DR. ROTZ: This is Lisa Rotz. You know, the earlier drafts of this plan has been out with the states for, I think since November of last year for them to begin their planning on how to put in place mechanisms for controlling a smallpox outbreak, including how they would select an isolation facility should an outbreak of smallpox occur in their community, and there are several different ways that they can implement that. And part of how quickly this could be put into place is how quickly states have been putting their plans together to do this, and I think each community has been working very diligently since last fall to put together the types of planning response that they would need to implement the control measures that they would need to do that.

And so from a Federal standpoint, we are ready to go as soon as we need to go, to bring all of our resources available online to assist states. And from a state standpoint, local standpoint, I think they are becoming more and more ready each day to implement as many control measures as they need to do to implement this plan.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: That's Michael Kranish with the Boston Globe. Please go ahead.

QUESTION: Yes, thank you. Can you be more specific on what are the adverse events, the likely percentage of deaths in both, when you have the smaller and then if you have nationwide. That obviously is going to play greatly into how many people do it, the voluntary nature and so forth. I have a follow up. Thank you.

DR. ORENSTEIN: The estimates of deaths come from data that are in the 1960s, and at that point it was roughly one death per million vaccinations. I would think in this population where we have more people with immune problems and more people with certain skin rashes that put them at greater risk of some of the severe complications, it would probably be a little bit higher than that, but that's the order of magnitude that we would be talking about. This is in marked contrast to smallpox itself, which in the past has been associated with a 300,000 per million death rate, so that we would think in a setting of a smallpox outbreak, the vast majority of people would react quite favorably to getting this vaccine.

In terms of the other adverse events, a variety of others that also occur, these include accidental inoculation, such as inoculation into the eye. It includes something called post vaccination encephalitis, which is an inflammation in the brain. It includes infection of the skin, something called eczema vaccinatum, which can be quite severe, and it's like a third-degree burn.

In terms of rates of those kinds of complications, overall, the rate of encephalitis were about 12 per million in the past. The rate of this severe eczema vaccinatum, which is a severe skin infection like a third-degree burn in patients with certain underlying skin diseases, was about 39 per million. And the other thing that we are quite concerned about is something called progressive vaccinia, which occurs in people who have abnormal immune systems in which the virus grows unchecked, and that occurs about 1 to 2 per million in the past.

QUESTION: So when you say there are certain groups that might be more at risk, you're talking about people who have the AIDS virus, things like that?

DR. ORENSTEIN: Exactly. There are a variety of groups that are more at risk of these adverse events. They include people with abnormal immune systems, so they include people with HIV infection, those who have certain cancers, those who are on medications that suppress their immune system, and a variety of others.

Then there's a group that have conditions often called eczema, which is a condition often associated with an allergic predisposition, and those people can develop severe skin infections.

And then there are certain age groups that are more at risk, such as very young children. Children under a year of age appear to have significantly higher risk of a number of these conditions including the severe encephalitis or brain inflammation.

CDC MODERATOR: Okay, thank you. Next question, please.

AT&T OPERATOR: That's from Jackie Judd, ABC News. Please go ahead.

QUESTION: Yes, good afternoon and thank you. Two questions. One, what is your last best estimate on when there will be enough vaccinations for every American?

And in the months since local communities have begun planning for this eventuality, what are you hearing back from them about what the largest hurdles will be to make this an effective campaign?

CDC MODERATOR: I'm sorry. Could you just repeat the second question.

QUESTION: Yes. Since local states and communities have begun making some initial plans for this kind of program, what are you hearing back from local public health officials about what the biggest hurdles will be to making this work?

MR. HENDERSON: This is Joe Henderson. I can address, partially, both of these questions.

On the vaccine availability, I think our feeling right now is that on an emergency basis, if we were to see smallpox tomorrow, we have access to vaccines that we feel could support mass vaccination if we had to on an emergency basis.

Of course, we continue to strive to have vaccines that are safe, that are licensed, and I think by the end of the year we'll have substantial quantities of vaccine. But right now if we had to, we could tie up some of our emergency resources if we had to vaccinate the entire population.

As far as your second question about what we're hearing back from state and local health agencies who were in various forms of preparedness around smallpox right now, we're hearing different things. A number of states have submitted plans for us to take a look at to get our sense of where they are. We're thinking that those states that have those plans are probably a lot closer to having exercises conducted, where they can demonstrate proficiency in responding to a smallpox event.

But I think the challenge right now for our projects in general is that there is somewhat of a focus on smallpox preparedness and response, but they are also building public health infrastructure to deal with all of the threats, our critical agents that are the pathogens, but also chemical releases, and low-yield nuclear, the dirty-bomb type of release and trying to understand the public health consequences of those types of terrorist events. So they are very, very busy on many, many fronts dealing with building the public health infrastructure to respond.

So we're looking to work with them and understand in more clear detail specific progress they're making on all of these fronts, and that's going to be the focus of our state and local program activity here at CDC to go out there and gather this information so we can characterize our national response in a much more comprehensive way.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: That's from Deanna Franklin, Internal Medicine News. Please go ahead.

QUESTION: Hi. Partly in the beginning, when you were talking, you mentioned your pre-event plan, and I was wondering when those prevaccination plans for medical personnel would be ready, and are those vaccinations set to begin towards the end of the year, which I read in one of the news stories? Also, will there be a hierarchy of who will get that vaccination first, like hospital personnel, and then, say, on to office-based practitioners.

MR. HENDERSON: This is Joe Henderson again.

We, here at CDC and the Department, continue to wait on a decision from the administration on pre-event strategies. We continue to influence that process, but I can't say there's anything concrete right now as far as a decision is concerned or what the time line is.

Walt, maybe you want to talk about this.

DR. ORENSTEIN: I think the other issue is, in the meantime, we are trying to get some of the technical issues and impediments that would have to be addressed to implement any pre-event vaccination, and we're working closely with our Advisory Committee on Immunization Practices, as well as our Hospital Infection Control Policy Advisory Committee, particularly on health care worker issues as to how they should be vaccinated, who might be a greatest priority for initial vaccination, wound site care, and what kinds of screening might be done in a pre-attack setting to determine who should, and who should not, get vaccinated.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: A.J. Hostetler, Richmond Times Dispatch. Please go ahead.

QUESTION: Hi. Good afternoon.

My question is this: What constitutes an attack of smallpox? Does any smallpox case surfacing, would that lead to this or is there a number of smallpox cases that would have to surface before this would be implemented? Can you talk about that, please?

DR. FLEMING: This is Dave Fleming.

Basically, given that smallpox has been eradicated from the world, a single case of smallpox, assuming that the evidence is that it's intentionally caused, would constitute an attack.

QUESTION: What would be the process to decide all of that? I mean, just beyond isolating a single case, and then you said that there were other considerations.

DR. FLEMING: As far as the exact response that would be the most effective one, that would depend on the nature of the case and the number of cases that occurred. But the critical fact to remember here, obviously, is that there is no smallpox right now, and so we are spending a lot of time, and energy, and resources working with our state and local partners to make sure that we're vigilant, that we have systems out there that can detect suspected cases and make definitive diagnosis one way or the other as quickly as possible.

In the event where we have a highly suspected case or a confirmed case, we would act, at that point, as if, if you will, the nation were under attack and would immediately implement this response plan.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: It is from Richard Knox, National Public Radio. Please go ahead.

QUESTION: Yes, I have a couple.

The first does follow on. I think we're all trying to understand better just what is the trigger for a mass-vaccination circumstance, and it's still not clear, I think, even despite Dr. Fleming's answer just now, whether a single case would trigger the big thing. It seems not, but if not, then what would be some of the circumstances. Maybe there's not a single answer that would trigger a mass-vaccination recommendation?

DR. ORENSTEIN: This is Walt Orenstein. I think the issue with a single case is an assessment would have to be made is this really the only single case or are there likely to be more cases around? Is there likely to be an ongoing attack? Those kinds of assessments would have to be made very rapidly, and to the extent that the presumption is that this is probably one case of many yet to come or it's more broad-based, then the decision to do mass vaccination would be made, and depending on where people thought the likelihood was of a significant attack would be how far spread, including potentially vaccinating the whole country.

So I think we would have to try and interpret what that one case would really mean, in terms of how broad that response would be. The likelihood, if it's a real attack, is that it would probably be one of potentially many, and I think we would have to implement a fairly widespread control program.

CDC MODERATOR: Do you have a follow-up?

QUESTION: Yes, thank you. That was helpful. Thank you.

Do you know when we might expect--I guess right now the CDC has estimated, at least according to its website materials, that there is enough vaccine immunoglobulin for about 600 people suffering from severe side effects. Do you know when we can expect a whole lot more to be available? And then sort of following on that, if I may, I gather that VIG doesn't really do anything in encephalitis, and children or young children are especially susceptible to encephalitis, so I'm wondering whether this document addresses children differently in terms of vaccination recommendations.

DR. ROTZ: This is Lisa Rotz.

As far as the question regarding VIG availability, CDC signed a contract with a company I think last month, actually, to produce an IV VIG product to increase our availability of VIG, and I believe that they've been asked to speed up their production process to include a substantial number of VIG doses by the end of the year, up to--well, I don't know the numbers exactly, but I know they've been asked to increase that. That would greatly increase our availability of VIG by the end of the year as an IV product.

In regards to addressing vaccine recommendations for small children, when we talk about a post-event setting or a post-event, large-scale vaccination program, again, as Dr. Orenstein said earlier, there are some groups of small children that would be more at risk for adverse events than others, and when we talk about children less than one year old, again, the assessment on whether or not they should be vaccinated in a post-event setting would depend upon their individual risks associated with coming into contact with smallpox.

In other words, from an adult standpoint, an adult is more mobile and moves around quite a bit, so their chances of coming into contact with somebody with smallpox would be greater overall in a post-event setting, if there were a lot of exposed people potentially out there, than a smaller child would.

I think we would work with individual parents to make a designation on whether or not a smaller child was at great risk to where the vaccination would be benefit them more than they would have risks from the vaccination.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: That's from Steve Mitchell, United Press International. Please go ahead.

QUESTION: Hi. It sounds like, with this kind of plan, putting this kind of plan in place, you guys are really focusing on a response that would come after an attack, at least a mass vaccination response. A number of people on the outside of this think that that would be inefficient in response to a bioterrorist attack. So I'm just wondering how you've factored those kinds of decisions into this and whether you actually looked at how this would play into preventing the spread of disease if there is a wide-scale attack in many different locales.

CDC MODERATOR: I'm not sure if we're clear on your question, but we're going to try to answer it.

DR. ORENSTEIN: I think, if I understood correctly, you're talking about should there be pre-event mass vaccinations so that you can have an overall layer of immunity before any attack, and perhaps prevent an attack from taking place; is that what you're aiming at?

QUESTION: Yes.

DR. ORENSTEIN: I think that, again, we are awaiting the policy decision with regard to that and will implement whatever decision is made.

I think if we look at smallpox transmission, based on importations into Europe during the '50s, '60s, and '70s, clearly, health care workers would be at greatest risk, which is why we have been speaking about vaccinating initially, as we increase our preparedness.

There are other issues with using vaccine under what's called an investigational new drug protocol that are complicated when dealing with very large-population vaccinations, particularly in a pre-attack setting. And so as vaccine becomes licensed, it makes the options a little more easier to implement in a pre-attack setting.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: That's from the line of Ira Dreyfus with the Associated Press Radio. Please go ahead.

QUESTION: Just for my radio purposes, the identity, firstly, of the person who was talking about the estimate of deaths from adverse events and that. I need to know that.

CDC MODERATOR: That was Dr. Walter Orenstein.

QUESTION: Good. I thought it was.

A second thing, just to be clear in my own mind, in the event of an outbreak on a state level or a couple of states, who has the final word; is that CDC telling the states how to operate, the states operating and telling CDC what they would like?

And the third question, just to be clear, the cost of the ring vaccination program is what? And the estimated cost of this more advanced, enhanced program is what?

MR. HENDERSON: This is Joe Henderson. I'll just mention our understanding, as far as how we perceive what we'll call command and control if we have multiple states involved in an outbreak response.

Of course, if we're talking about two or three states, CDC--and this is, again, short of a presidential declaration, some type of an emergency--the CDC will continue to work with the state and local health agencies in those jurisdictions.

We support their response activities. The response in those particular communities are going to be led at the state level clearly by the state emergency management folks and their public health officers. Regional approaches, we will facilitate a regional approach to ensure they have the resources they need to continue to conduct disease investigations, et cetera, but we still see those particular outbreaks being led by those jurisdictions with our overall support and the support of the Department of Health and Human Services.

DR. ORENSTEIN: But I think we will have to have a Federal role because, obviously, we don't want one state to be a reservoir for other states, and so you have to have a central coordination with those states, and we would feel, in the setting of an outbreak, that that would work pretty well.

QUESTION: And that was whom speaking?

DR. ORENSTEIN: Walter Orenstein.

QUESTION: Thank you.

DR. FLEMING: This is Dr. Fleming.

With respect to the costs, the costs of any sort of vaccine program is, to a certain extent, most dependent on the number of people who are being immunized because that's what takes up the resources, that's what takes up the vaccine.

So, clearly, a program that targeted tens of thousands or even hundreds of thousands of people would be less expensive than a program that targeted 300 million people.

On the other hand, in the situation we're talking about, where there was an outbreak of smallpox and the determination was made that the U.S. population was at ongoing or continuing risk, at that point, the costs of immunizing the population would be less, both in terms of illness and death, not just economic costs, than not vaccinating people.

So it's a cost-effectiveness compared to the risk that's being prevented that you need to factor into that question.

QUESTION: Just one last question, and that is to be absolutely clear on it. There must be some budgeted amount or at least some ballpark figure in there, and maybe you have it figured on an intent-to-treat basis or something, but there has to be some dollars on it, and I suspect you guys might know them.

DR. FLEMING: I think that a reasonable figure to use is on the order of $5 to $10 per person immunized. There is an economy of scale such that smaller scale campaigns would be more expensive proportionately than larger scale campaigns.

QUESTION: That's Doctor?

DR. FLEMING: Fleming.

QUESTION: Thank you.

CDC MODERATOR: Thank you. Next question, please.

AT&T OPERATOR: That's from Elizabeth Cohen, CNN. Please go ahead.

QUESTION: Hi. Thank you for having this telebriefing.

I feel like we didn't get a real answer to Jackie Judd's question earlier, which was do we have enough vaccine for every man, woman and child in the United States? The answer was we have enough for mass vaccinations. Does that mean we have enough for everybody or for half or for a quarter or for Dekalb County? I mean, what does that mean? What do you have?

MR. HENDERSON: This is Joe Henderson, again. I can tell you that, on an emergency basis, if we saw smallpox tomorrow, and we felt there was a national need to do mass vaccination, we have adequate vaccine that we feel could immunize about 155 million individuals, and we're working diligently to look at other stocks of vaccine to see if there are efficacious, through some dilutional studies, that would expand that by the end of this year to cover the entire population.

QUESTION: And then the follow-up question is, if there was, you know, God forbid, some kind of massive outbreak, does the government have the police power to require people to get vaccinated?

DR. FLEMING: This is Dr. Fleming. The government has, in these situations, police power to do what's necessary to protect both individuals who are affected and the public. That, in situations like this, would probably not play out because, as Dr. Orenstein mentioned, when you're looking at a disease that has a 30-percent mortality if you go unvaccinated, our census, and certainly history, shows that people willingly do get vaccinated.

If there were a rare instance where, for whatever reason someone did not want to or were unable to become vaccinated because of medical conditions, we would assure that that person was in a setting where they could be monitored and that appropriate medical care could be delivered to them if they became sick, and if they became sick, that they would not inadvertently expose others.

CDC MODERATOR: Thank you. Next question?

AT&T OPERATOR: It's from Marsha Clement, Medicine and Health. Please go ahead.

QUESTION: Hi. I have a couple more questions about the cost. First, whether that $5- or $10-estimate, whether that includes a lot of the surroundings of this short-time vaccination such as possibly transportation of people to places, a lot of overtime. I understand there can be very serious side effects, so what kind of follow-up are we talking about in terms of having these people have bad reactions and come back within the next few days.

All of that is a money problem in the sense, to me, that we're hearing right now that the local and state public health agencies are having enormous difficulty and need an influx of funds simply to deal with West Nile, which isn't very widespread and involves mosquito abatement, which I thought was a very standard public health thing that you do every year.

So are the states and localities telling you that they have enough money to gear up in five or ten days, at the drop of a hat, to carry out these programs or is that going to raise a financial issue, and then after the fact, who would pay the bill for what they spent in that five- or ten-day period?

DR. FLEMING: This is Dr. Fleming. I'm going to answer part of that, then Dr.--then Joe Henderson will talk, but basically the 5 to $10 figure at the back of the envelope, accrued figure that is one that would not include the cost that you had mentioned. I think though the important thing here, obviously, is that we're talking about a decision that for the most part is one that we want to make based on how many lives we can save as opposed to what's the most expensive option?

Please hear that the economy of this is important, but much more important to us and to the country is that we do the right things to keep people alive and healthy and well.

MR. HENDERSON: This is Joe Henderson. Just a follow to that, and to answer your question about cost at the state and local level, you know, we, in February, CDC and the Department of Health and Human Services pushed about $918 million out the door to build broad-based public health infrastructure to deal with a variety of bioterrorism preparedness and response activities. And the states right now have a lot of that money programmed to do a number of different things.

And so the question is, is that enough money to support the preparedness and response activities that the state and local health agencies will need to deal with these events, not only in preparing for them, but also to respond to them and to respond to something as horrible as a smallpox outbreak that's taking into account a large percentage of their jurisdiction. We don't know. One of the things we're asking them and we'll deal with in our evaluation process is to find out what are the long-term sustaining costs needed to ensure a public health system is ready and what will be the congressional needs in the years to come to sustain that infrastructure.

So this is a work in progress, and just understand that this money we sent out from CDC was the most we've ever sent out to support one project, and that the state and local health agencies are struggling with a variety of budget issues right now, most of them being shrinking budget, but this is a slow process, but we hope to have that information more definitive in the months ahead.

CDC MODERATOR: Thank you very much. We have time for one more question.

AT&T OPERATOR: That will be from Adam Marcus, Healthscope. Please go ahead.

QUESTION: Hi, thanks for holding the briefing. I'm just curious if you can envision a situation in which once you--once one state gets down the road towards mass vaccination you wouldn't be forced to have a mass vaccination in every state?

DR. FLEMING: And this is Dr. Fleming. In the situation that we're talking about, we're looking at what the most appropriate strategy is. While it is true that individual states have some leeway, this would be, in fact, you know, a national emergency and a national decision. We, on a day-to-day basis do routinely deal with state health departments on issues that cross jurisdictional boundaries, and in this setting we are going to have an event that's coordinated. And decisions regarding vaccination will be made at the Federal level as far as deciding what is in the best interest for the country as a whole.

So I really can't foresee a scenario where we're going to have one state choosing to do one thing and one state choosing to do something else. We're working very closely with our state and local partners on this. But this would constitute a national emergency, and there will be a Federal decision on what the best approach is.

CDC MODERATOR: Thank you. And that concludes our telebriefing for today.

Listen to the telebriefing

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